{"article":{"annotation":{"article_id":"italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026","available_at":"2026-10-18T23:00:44.205658Z","geography_revision":"ef6ee0010dda5fe7b240fd514749b43e214c57da73222d2e40ec83b276dd0977","id":"91607dc32224bfc2b76f4fcb5f464a5d976ae5d31ad8fcb0e809adef5c6530b6","input_sha256":"59f92305552651aaeb0c296b9178e59220c41657688b881e22c40e287b45b9ac","limitations":["Rule-derived subjects are candidates, not verified editorial labels or calibrated model probabilities.","Coverage is distinct from event location. Unknown country/city/coordinates remain absent; no automatic geocoding.","Article geometries keep their stated precision and methodology; reproducing them is not independent coordinate verification."],"method":"controlled-rules-v1","places":[{"admin1":null,"city":null,"coordinate_note":null,"coordinate_reference_system":"OGC:CRS84","coordinate_source":null,"country":"IT","evidence":[{"field":"country","language":"en","note":"Explicit preserved editorial country/region; no city or national centroid inferred","source_urls":["https://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.codiceRedazionale=26A05366&atto.dataPubblicazioneGazzetta=2026-10-17&atto.tipoProvvedimento=DETERMINA"]}],"geometry":null,"id":"iso3166-1:IT","kind":"country-or-area","labels":{"ar":"إيطاليا","en":"Italy","es":"Italia","fr":"Italie"},"match_status":"candidate","precision":"regional","role":"coverage","uncertainty_m":null}],"rules_sha256":"fb5ad3c27c91cb840f7a0a05f7f64a5cb26ad0374409ff9457f277c7092e22b4","schema_version":1,"subjects":[{"concept_id":"medtop:07000000","confidence":null,"confidence_method":null,"evidence":[{"field":"category+topics","language":"en","note":"Preserved editorial category/topic; broad candidate only","source_urls":["https://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.codiceRedazionale=26A05366&atto.dataPubblicazioneGazzetta=2026-10-17&atto.tipoProvvedimento=DETERMINA"]}],"method":"controlled-rules-v1","rule_id":"health-broad","status":"candidate"}],"taxonomy_revision":"1f2db31d811fca07e99b16d402c10e2cc2965c9df1c7b41d9be348b40a24e7fb","taxonomy_version":"IPTC Media Topics 2026-Q2"},"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=de","category":"health","content":{"key_points":[],"paragraphs":["Die drei auf den 1. Oktober datierten Entscheidungen der AIFA wurden am 17. Oktober im italienischen Amtsblatt veröffentlicht. Sie stufen Itvisma mit Onasemnogen-Abeparvovec, Jascayd mit Nerandomilast und Liraglutide Stada mit Liraglutid als neu zugelassene Humanarzneimittel ein.","Die Entscheidungen traten am 18. Oktober in Kraft. Alle drei Präparate wurden der Klasse C(nn) zugeordnet, die laut AIFA für Arzneimittel vorgesehen ist, deren Erstattungsfähigkeit noch nicht bewertet wurde. Die Einstufung ist für sich genommen weder eine Erstattungsentscheidung noch eine Bestätigung des Verkaufsbeginns. Ein separates AIFA-Dokument zur Abgabe für die Sitzung vom 7. bis 11. September sieht für Itvisma eine ausschließliche Anwendung im Krankenhaus und für Liraglutide Stada eine Abgabe auf Rezept vor."],"sections":[]},"corrections":[],"country":"IT","data":{"blocks":[{"columns":[{"key":"product","label":{"ar":"الدواء","de":"Arzneimittel","en":"Medicine","es":"Medicamento","fr":"Médicament","pt":"Medicamento","tr":"İlaç"},"language":"en","type":"text"},{"key":"active_substance","label":{"ar":"المادة الفعالة","de":"Wirkstoff","en":"Active substance","es":"Principio activo","fr":"Substance active","pt":"Substância ativa","tr":"Etken madde"},"language":"en","type":"text"},{"key":"class","label":{"ar":"فئة تقييم التعويض","de":"Erstattungsbewertungsklasse","en":"Reimbursement assessment class","es":"Clase de evaluación del reembolso","fr":"Classe d’évaluation du remboursement","pt":"Classe de avaliação do reembolso","tr":"Geri ödeme değerlendirme sınıfı"},"language":"en","type":"text"}],"description":{"ar":"اتُخذت القرارات في 1 أكتوبر وأدرجت كل منتج في الفئة C(nn) قبل تقييم التعويض.","de":"Die Entscheidungen ergingen am 1. Oktober; jedes Präparat wurde vor einer Erstattungsbewertung der Klasse C(nn) zugeordnet.","en":"The determinations were adopted on 1 October and place each product in class C(nn), before reimbursement assessment.","es":"Las decisiones se adoptaron el 1 de octubre y sitúan cada producto en la clase C(nn), antes de evaluar el reembolso.","fr":"Les décisions ont été prises le 1er octobre et placent chaque produit en classe C(nn), avant évaluation du remboursement.","pt":"As decisões foram adotadas em 1 de outubro e colocam cada produto na classe C(nn), antes da avaliação de reembolso.","tr":"Kararlar 1 Ekim’de kabul edildi ve her ürün henüz geri ödeme değerlendirmesi yapılmamış C(nn) sınıfına yerleştirildi."},"id":"aifa-new-medicine-classifications","methodology":{"ar":"الفئات والمواد الفعالة مأخوذة من قرارات الهيئة. ولا يعني الإدراج في C(nn) اكتمال تقييم التعويض.","de":"Klassen und Wirkstoffe stammen aus den AIFA-Entscheidungen. Die Einstufung C(nn) bedeutet nicht, dass die Erstattungsbewertung abgeschlossen ist.","en":"Classes and active substances are taken from AIFA’s determinations. C(nn) placement does not mean reimbursement assessment is complete.","es":"Las clases y principios activos proceden de las decisiones de AIFA. La inclusión en C(nn) no significa que haya concluido la evaluación del reembolso.","fr":"Classes et substances actives proviennent des décisions de l’AIFA. Le classement C(nn) ne signifie pas que l’évaluation du remboursement est achevée.","pt":"As classes e substâncias ativas constam das decisões da AIFA. A inclusão em C(nn) não significa que a avaliação do reembolso esteja concluída.","tr":"Sınıf ve etken maddeler AIFA karar metinlerinden alınmıştır. C(nn) yerleşimi geri ödeme değerlendirmesinin tamamlandığını göstermez."},"rowTranslations":[{"active_substance":{"ar":"أوناسمنوجين أبيبارفوفيك","de":"Onasemnogen-Abeparvovec","en":"onasemnogene abeparvovec","es":"onasemnogén abeparvovec","fr":"onasemnogène abéparvovec","pt":"onasemnogene abeparvovec","tr":"onasemnogene abeparvovec"},"class":{"ar":"C(nn) - لم يُقيّم التعويض بعد","de":"C(nn) - Erstattungsfähigkeit noch nicht bewertet","en":"C(nn) - not yet assessed for reimbursement","es":"C(nn) - reembolso aún no evaluado","fr":"C(nn) - remboursement pas encore évalué","pt":"C(nn) - reembolso ainda não avaliado","tr":"C(nn) – geri ödeme açısından henüz değerlendirilmedi"},"product":{"ar":"إيتفيسما","de":"Itvisma","en":"Itvisma","es":"Itvisma","fr":"Itvisma","pt":"Itvisma","tr":"Itvisma"}},{"active_substance":{"ar":"نيرانْدوميلاست","de":"Nerandomilast","en":"nerandomilast","es":"nerandomilast","fr":"nérandomilast","pt":"nerandomilast","tr":"nerandomilast"},"class":{"ar":"C(nn) - لم يُقيّم التعويض بعد","de":"C(nn) - Erstattungsfähigkeit noch nicht bewertet","en":"C(nn) - not yet assessed for reimbursement","es":"C(nn) - reembolso aún no evaluado","fr":"C(nn) - remboursement pas encore évalué","pt":"C(nn) - reembolso ainda não avaliado","tr":"C(nn) – geri ödeme açısından henüz değerlendirilmedi"},"product":{"ar":"جاسكايد","de":"Jascayd","en":"Jascayd","es":"Jascayd","fr":"Jascayd","pt":"Jascayd","tr":"Jascayd"}},{"active_substance":{"ar":"ليراغلوتايد","de":"Liraglutid","en":"liraglutide","es":"liraglutida","fr":"liraglutide","pt":"liraglutido","tr":"liraglutide"},"class":{"ar":"C(nn) - لم يُقيّم التعويض بعد","de":"C(nn) - Erstattungsfähigkeit noch nicht bewertet","en":"C(nn) - not yet assessed for reimbursement","es":"C(nn) - reembolso aún no evaluado","fr":"C(nn) - remboursement pas encore évalué","pt":"C(nn) - reembolso ainda não avaliado","tr":"C(nn) – geri ödeme açısından henüz değerlendirilmedi"},"product":{"ar":"ليراغلوتايد ستادا","de":"Liraglutide Stada","en":"Liraglutide Stada","es":"Liraglutide Stada","fr":"Liraglutide Stada","pt":"Liraglutide Stada","tr":"Liraglutide Stada"}}],"rows":[{"active_substance":"onasemnogene abeparvovec","class":"C(nn) - not yet assessed for reimbursement","product":"Itvisma"},{"active_substance":"nerandomilast","class":"C(nn) - not yet assessed for reimbursement","product":"Jascayd"},{"active_substance":"liraglutide","class":"C(nn) - not yet assessed for reimbursement","product":"Liraglutide Stada"}],"sourceUrls":["https://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.codiceRedazionale=26A05366&atto.dataPubblicazioneGazzetta=2026-10-17&atto.tipoProvvedimento=DETERMINA"],"title":{"ar":"ثلاثة تصنيفات دوائية نشرتها الهيئة في 17 أكتوبر","de":"Drei Arzneimitteleinstufungen der AIFA vom 17. Oktober","en":"Three medicine classifications published by AIFA on 17 October","es":"Tres clasificaciones de medicamentos publicadas por AIFA el 17 de octubre","fr":"Trois classifications de médicaments publiées par l’AIFA le 17 octobre","pt":"Três classificações de medicamentos publicadas pela AIFA em 17 de outubro","tr":"AIFA’nın 17 Ekim’de yayımladığı üç ilaç sınıflandırması"},"type":"table","updatedAt":"2026-10-18T22:08:02Z"}],"version":1},"data_downloads":[{"formats":{"csv":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026/data/aifa-new-medicine-classifications?lang=de&format=csv","json":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026/data/aifa-new-medicine-classifications?lang=de&format=json"},"id":"aifa-new-medicine-classifications"}],"data_types":["table"],"editorial_illustration":{"alt":"Konzeptionelle Darstellung von öffentlicher Gesundheit, Forschung und vernetzten Daten.","asset_id":"newsverum-v1-health","avif_variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.avif","width":480},{"height":480,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-720.avif","width":720},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.avif","width":960},{"height":800,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1200.avif","width":1200},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.avif","width":1536}],"credit":"Newsverum","documentary":false,"height":1024,"kind":"symbolic-editorial-illustration","language":"de","scope":"topic","url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.webp","width":480},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.webp","width":960},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","width":1536}],"width":1536},"event_id":"event-2046d0ae-ea54-5d54-8426-aac66d609f37","event_period":"2026-10-18","event_period_basis":"event-or-reference-period","id":"italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026","image":null,"importance":0.6,"language":"de","modified_at":"2026-10-18T23:00:19+00:00","publication_basis":"publication-record","published_at":"2026-10-18T23:00:19+00:00","reading_minutes":1,"region":"world","section_illustration":{"alt":"Konzeptionelle Darstellung von öffentlicher Gesundheit, Forschung und vernetzten Daten.","asset_id":"newsverum-v1-health","avif_variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.avif","width":480},{"height":480,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-720.avif","width":720},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.avif","width":960},{"height":800,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1200.avif","width":1200},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.avif","width":1536}],"credit":"Newsverum","documentary":false,"height":1024,"kind":"symbolic-editorial-illustration","language":"de","scope":"section","url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.webp","width":480},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.webp","width":960},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","width":1536}],"width":1536},"slug":"italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026","sources":[{"checkedAt":"2026-10-19","name":"Agenzia Italiana del Farmaco (AIFA)","publishedAt":"2026-10-17","url":"https://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.codiceRedazionale=26A05366&atto.dataPubblicazioneGazzetta=2026-10-17&atto.tipoProvvedimento=DETERMINA"}],"summary":"Die italienische Arzneimittelagentur veröffentlichte am 17. Oktober Entscheidungen vom 1. Oktober zu Itvisma, Jascayd und Liraglutide Stada. Alle drei wurden der Klasse C(nn) für noch nicht auf Erstattungsfähigkeit bewertete Arzneimittel zugeordnet.","text":"Die italienische Arzneimittelagentur veröffentlichte am 17. Oktober Entscheidungen vom 1. Oktober zu Itvisma, Jascayd und Liraglutide Stada. Alle drei wurden der Klasse C(nn) für noch nicht auf Erstattungsfähigkeit bewertete Arzneimittel zugeordnet.\n\nDie drei auf den 1. Oktober datierten Entscheidungen der AIFA wurden am 17. Oktober im italienischen Amtsblatt veröffentlicht. Sie stufen Itvisma mit Onasemnogen-Abeparvovec, Jascayd mit Nerandomilast und Liraglutide Stada mit Liraglutid als neu zugelassene Humanarzneimittel ein.\n\nDie Entscheidungen traten am 18. Oktober in Kraft. Alle drei Präparate wurden der Klasse C(nn) zugeordnet, die laut AIFA für Arzneimittel vorgesehen ist, deren Erstattungsfähigkeit noch nicht bewertet wurde. Die Einstufung ist für sich genommen weder eine Erstattungsentscheidung noch eine Bestätigung des Verkaufsbeginns. Ein separates AIFA-Dokument zur Abgabe für die Sitzung vom 7. bis 11. September sieht für Itvisma eine ausschließliche Anwendung im Krankenhaus und für Liraglutide Stada eine Abgabe auf Rezept vor.","title":"AIFA ordnet drei neue Arzneimittel einer Klasse vor der Erstattungsbewertung zu","topics":[],"translations":[{"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=tr","language":"tr","url":"https://newsverum.com/tr/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},{"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=en","language":"en","url":"https://newsverum.com/en/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},{"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=ar","language":"ar","url":"https://newsverum.com/ar/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},{"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=fr","language":"fr","url":"https://newsverum.com/fr/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},{"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=es","language":"es","url":"https://newsverum.com/es/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},{"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=de","language":"de","url":"https://newsverum.com/de/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},{"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=pt","language":"pt","url":"https://newsverum.com/pt/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"}],"url":"https://newsverum.com/de/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},"version":"1"}